FDA’s OPQ Adapts ANDA Risk-Ranking Model for Drug Substance Reviews

FDA’s Office of Pharmaceutical Quality (OPQ) has adapted the risk-ranking model developed for abbreviated new drug application (ANDA) reviews to its review of drug substances, with the goal of improving communications internally and with industry regarding API risks and deficiencies, and in turn, the overall efficiency and predictability of the process.

The risk-ranking system allows the primary drug substance reviewers to more readily communicate the risks they see to their team and branch leadership, and facilitates the further discussions that take place through the new integrated team review process with the drug application review staff.  It is also intended to ensure that the numbers and types of deficiencies being conveyed to industry are reflective of the risk involved.

How the risk model was developed and is being implemented was addressed by OPQ Office of New Drug Products (ONDP) Acting Life Cycle Branch Chief Deborah Johnson at the GPhA Fall Technical Conference in November in Bethesda, Maryland.

In her talk, Johnson discussed the impact of the new risk-based approach on the six areas of most concern in drug master file (DMF) reviews:  ● starting materials ● the manufacturing process ● identification and characterization of the API ● organic impurities ● residual solvents and elemental impurities, and ● stability.

She proceeded to go over what the reviewers are looking for and what industry can do to make the DMF assessment process go more smoothly.

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